Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

How much? Pfiz­er ex­pects to reap at least $26B from Covid vac­cine in 2021

Pfiz­er’s Covid-19 vac­cine is like­ly to bring in about $26 bil­lion in 2021 rev­enues, which is more than $10 bil­lion more than the bio­phar­ma be­he­moth pre­vi­ous­ly pre­dict­ed, the com­pa­ny an­nounced Tues­day morn­ing.

The com­pa­ny said that fig­ure is based on signed con­tracts as of mid-April that amount to 1.6 bil­lion dos­es of the vac­cine to be de­liv­ered this year. And the dra­mat­ic uptick in guid­ance is due to ad­di­tion­al sup­ply agree­ments that have been signed since the com­pa­ny’s pre­vi­ous guid­ance. More may be com­ing too.

“We al­so are in on­go­ing dis­cus­sions with mul­ti­ple coun­tries around the world about their needs, and we ex­pect these dis­cus­sions to lead to ad­di­tion­al sup­ply agree­ments,” Pfiz­er CEO Al­bert Bourla said in pre­pared re­marks on Tues­day’s con­fer­ence call.

To put in­to per­spec­tive how much $26 bil­lion is for Pfiz­er: It’s more than any oth­er drug or vac­cine has earned in a year, ever. And it’s al­most 30% of what the com­pa­ny ex­pects in to­tal rev­enues for 2021, and it’s more than dou­ble what the com­pa­ny ex­pects to spend on R&D (about $10 bil­lion in 2021).

“Fac­tor­ing in the costs to man­u­fac­ture, mar­ket and dis­trib­ute BNT162b2 [the vac­cine], in­clud­ing ap­plic­a­ble roy­al­ty ex­pens­es and a 50% gross prof­it split with BioN­Tech, as well as shared R&D ex­pens­es re­lat­ed to BNT162b2 and costs as­so­ci­at­ed with oth­er as­sets cur­rent­ly in de­vel­op­ment for the pre­ven­tion and treat­ment of COVID-19, the rev­enue im­pact on the bot­tom line of our fi­nan­cials is an­tic­i­pat­ed to be in the high 20s as a per­cent­age of rev­enue,” a Pfiz­er spokesper­son said.

As of May 3, Pfiz­er and its part­ner BioN­Tech have shipped about 430 mil­lion dos­es of their vac­cine to 91 coun­tries and ter­ri­to­ries around the world, the com­pa­nies said. Al­ready in the first quar­ter of 2021, Pfiz­er said its vac­cine con­tributed $3.5 bil­lion in glob­al rev­enues, which com­pares with $154 mil­lion in sales in the fourth quar­ter of 2020 (the vac­cine won emer­gency use au­tho­riza­tion from the FDA in De­cem­ber).

Bourla al­so not­ed that the com­pa­ny ex­pects to sub­mit an ap­pli­ca­tion to the FDA for a full ap­proval of the vac­cine this month.

Be­yond 2021, the com­pa­ny said it’s al­ready held ne­go­ti­a­tions with Cana­da to sup­ply up to 125 mil­lion dos­es in 2022 and 2023, with op­tions to pur­chase up to 60 mil­lion ad­di­tion­al dos­es in 2024, and with Is­rael to sup­ply mil­lions of dos­es in 2022 and be­yond. Talks with oth­er coun­tries are on­go­ing too and Pfiz­er notes that it us­es three pric­ing tiers for gov­ern­ment con­tracts de­pend­ing on the rel­a­tive wealth of na­tions.

Those ad­di­tion­al dos­es will re­quire ad­di­tion­al man­u­fac­tur­ing ca­pac­i­ty, which the com­pa­ny ex­pects to have as it’s plan­ning for ca­pac­i­ty to man­u­fac­ture at least 3 bil­lion dos­es of the vac­cine in 2022, which com­pares with 2.5 bil­lion dos­es this year.

Use of the vac­cine is ex­pect­ed to soon ex­pand in the US for ado­les­cents aged 12 to 15, and the com­pa­ny ex­pects to have de­fin­i­tive read­outs and sub­mit for an EUA for two oth­er groups of chil­dren aged 2 to 5 years and 5 to 11 years, both in Sep­tem­ber, Bourla not­ed.

Pfiz­er is al­so work­ing on tri­als to test the vac­cine against vari­ants.

Bourla said the com­pa­ny is eval­u­at­ing the safe­ty and im­muno­genic­i­ty of a third dose of the ex­ist­ing for­mu­la­tion of its vac­cine “to un­der­stand the ef­fect of a boost­er on im­mu­ni­ty against the SARS-CoV-2 vari­ants in cir­cu­la­tion. Ad­di­tion­al­ly, we have start­ed an eval­u­a­tion of an up­dat­ed, pro­to­type vari­ant ver­sion of our vac­cine that en­codes the spike pro­tein of the lin­eage B.1.351 SARS-CoV-2 vari­ant, which in­cludes the mu­ta­tion E484K, first iden­ti­fied in South Africa.

“This study is de­signed to es­tab­lish a reg­u­la­to­ry path­way to up­date the cur­rent vac­cine to ad­dress any fu­ture vari­ant of po­ten­tial con­cern in ap­prox­i­mate­ly 100 days, if need­ed. We ex­pect to have im­muno­genic­i­ty da­ta for both stud­ies in ear­ly Ju­ly,” he added.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Vas Narasimhan, Novartis CEO (Thibault Camus/Pool via AP Images)

With gener­ic com­pe­ti­tion heat­ing up, Vas Narasimhan out­lines No­var­tis' growth plans at R&D day

Thursday marks Novartis’ annual R&D day, and with it comes CEO Vas Narasimhan’s attempt to spotlight the company’s pipeline strategy and emerging stars.

The biggest question entering Thursday’s presentation dealt with how the big biopharma will make up revenues from upcoming generic competition — Novartis says within the next five years, generics will eat away roughly $9 billion in sales. To offset this, Narasimhan outlined a strategy for 4% growth or higher until 2026, focusing on six key medicines he believes will see multibillion dollar profits during this time.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

As first Omi­cron case in US crops up, re­searchers won­der: Which an­ti­bod­ies, vac­cines will hold up?

As Covid-19 drug and vaccine developers race to figure out which of their products might be hampered by the new variant, the CDC on Wednesday afternoon announced the first confirmed case of the Omicron variant (B.1.1.529) in the US, found in San Francisco.

The unidentified individual was a traveler who returned from South Africa on Nov. 22, 2021, was fully vaccinated, and had mild symptoms that the CDC described as improving. All close contacts have been contacted and have tested negative, the centers said.

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